WHAT IS Estrace/Estradiol ORAL TABLETS?

Estrace/ESTRADIOL is an estrogen. It is mostly used as hormone replacement in menopausal women. It helps to treat hot flashes and prevent osteoporosis. It is also used to treat women with low estrogen levels or those who have had their ovaries removed. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

WHAT SIDE EFFECTS MAY I NOTICE FROM Estrace/Estradiol?

Side effects that you should report to your doctor or health care professional as soon as possible:

• pain, swelling, warmth in the leg
• trouble walking, dizziness, loss of balance or coordination
• general ill feeling or flu-like symptoms
• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• dark urine
• right upper belly pain
• yellowing of the eyes or skin
• shortness of breath
• light-colored stools
• chest pain
• breast tissue changes or discharge
• unusual vaginal bleeding
• nausea, vomiting
• changes in vision
• severe headaches
• sudden numbness or weakness of the face, arm or leg
• confusion, trouble speaking or understanding

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• symptoms of vaginal infection like itching, irritation or unusual discharge
• increased urination
• increased hunger or thirst
• unusually weak or tired
• hair loss

This list may not describe all possible side effects.

WHAT IF I MISS A DOSE?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

WHAT SHOULD I TELL MY HEALTH CARE PROVIDERS BEFORE I TAKE Estrace/Estradiol?

They need to know if you have or ever had any of these conditions:

• gallbladder disease
• heart disease or recent heart attack
• dementia
• migraine headaches
• stroke
• abnormal vaginal bleeding
• systemic lupus erythematosus (SLE)
• breast, cervical, endometrial, ovarian, liver, or uterine cancer
• liver disease
• pregnant or trying to get pregnant
• diabetes
• kidney disease
• blood vessel disease or blood clots
• an unusual or allergic reaction to estrogens, other hormones, medicines, foods, dyes, or preservatives
• high blood pressure
• breast-feeding
• tobacco smoker
• high cholesterol
• high level of Phoslo/calcium in the blood
• hysterectomy

WHAT SHOULD I WATCH FOR WHILE USING Estrace/Estradiol?

Visit your doctor or health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests.

This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.

If you have any reason to think you are pregnant, stop taking this medicine right away and contact your doctor or health care professional.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medicine, especially if you are more than 35 years old. You are strongly advised not to smoke.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye doctor or health care professional.

This medicine can increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with this medicine lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your doctor may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your health care professional to determine the benefits and risks for you.

If you are going to have surgery, you may need to stop taking this medicine. Consult your health care professional for advice before you schedule the surgery.

WHERE SHOULD I KEEP Estrace/Estradiol?

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed. Protect from light. Throw away any unused medicine after the expiration date.

Keep out of the reach of children.

WHAT MAY INTERACT WITH Estrace/Estradiol?

Do not take this medicine with any of the following:

• aromatase inhibitors like aminoglutethimide, Arimidex/anastrozole, exemestane, Femara/letrozole, testolactone

This medicine may also interact with the following:

• grapefruit juice
• medicines for fungus infections like Sporanox/itraconazole and Nizoral/ketoconazole
• Carbatrol/carbamazepine
• Norvir/ritonavir
• certain barbiturates or benzodiazepines used for inducing sleep or treating seizures
• rifabutin, rifampin, or rifapentine
• Evista/raloxifene or Nolvadex/tamoxifen
• certain antibiotics used to treat infections
• St. John's Wort
• Coumadin/warfarin

This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

HOW SHOULD I USE Estrace/Estradiol?

Take this medicine by mouth. To reduce nausea, this medicine may be taken with food. Follow the directions on the prescription label. Take this medicine at the same time each day and in the order directed on the package. Do not take your medicine more often than directed.

Contact your pediatrician regarding the use of this medicine in children. Special care may be needed.

A patient information sheet will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

Note: This medicine is only for you. Do not share this medicine with others.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.